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WO2012090186A1 - Auto-injecteurs résistant au glissement - Google Patents

Auto-injecteurs résistant au glissement Download PDF

Info

Publication number
WO2012090186A1
WO2012090186A1 PCT/IB2011/056031 IB2011056031W WO2012090186A1 WO 2012090186 A1 WO2012090186 A1 WO 2012090186A1 IB 2011056031 W IB2011056031 W IB 2011056031W WO 2012090186 A1 WO2012090186 A1 WO 2012090186A1
Authority
WO
WIPO (PCT)
Prior art keywords
label
autoinjector
housing
slip
exterior surface
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2011/056031
Other languages
English (en)
Inventor
John Glyndwr Wilmot
Mark Bump BREMLEY
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Meridian Medical Technologies Inc
Original Assignee
Meridian Medical Technologies Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Meridian Medical Technologies Inc filed Critical Meridian Medical Technologies Inc
Priority to JP2013546819A priority Critical patent/JP2014503308A/ja
Priority to US13/976,494 priority patent/US20130281934A1/en
Priority to EP11813825.4A priority patent/EP2658588A1/fr
Publication of WO2012090186A1 publication Critical patent/WO2012090186A1/fr
Anticipated expiration legal-status Critical
Priority to US15/259,145 priority patent/US20160375196A1/en
Priority to US16/125,926 priority patent/US20190022319A1/en
Priority to US16/913,042 priority patent/US11844932B2/en
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3137—Specially designed finger grip means, e.g. for easy manipulation of the syringe rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/586—Ergonomic details therefor, e.g. specific ergonomics for left or right-handed users

Definitions

  • the present invention relates to an autoinjector that has one or more slip- resistant features.
  • the features are designed to improve the handling properties of the autoinjector and reduce the likelihood that the autoinjector will slip out of a user's or caregiver's hand during use.
  • an autoinjector has become quite popular and have experienced widespread use due to a variety of advantages autoinjectors have over typical manual syringe injectors.
  • a number of autoinjectors are currently commercially available, including EpiPen® (King Pharmaceuticals Inc.), Anapen® (Lincoln Medical Ltd.), Rebiject® II (EMD Serono and Pfizer Inc.), and SureClickTM (Amgen).
  • an autoinjector is an automatic injection system that is designed to deliver a specific dosage of a medicament into an individual.
  • autoinjectors generally comprise a housing having an exterior surface and an interior surface and a proximal and distal end, a medicament situated within the housing, a needle, and an activateable power assembly. After activation of the power assembly, the needle moves from a storage position in which the needle is situated within the housing to a medicament delivering position in which the needle extends out of the proximal end of the housing and delivers the medicament to a patient.
  • a label containing, for example, instructions on how to use the autoinjector as well as a UPC code is attached to, and covers, a portion of the exterior surface of the autoinjector housing.
  • Such labels often have a slippery surface, which may decrease the handling properties of the autoinjector and increase the potential for the autoinjector to slip out of a user's or caregiver's hand.
  • the present invention provides an autoinjector that has one or more slip-resistant features.
  • the exterior surface of the autoinjector housing forms at least one of indentures and protrusions that impart a slip-resistant texture to the housing of the autoinjector.
  • the one or more slip-resistant features are included on a label, which comprises a label substrate and is attached to the exterior surface of the housing of the autoinjector.
  • the label comprises a label substrate and a varnish, wherein the varnish coats at least a portion of the label substrate.
  • the label comprises a label substrate having at least one of indentures and protrusions.
  • the label comprises a label substrate and a film, wherein the film coats at least a portion of the label substrate and provides a matte finish to at least a portion of the label.
  • slip-resistant features disclosed herein may be combined and the one or more slip-resistant features can be employed in any suitable autoinjector device.
  • the slip-resistant features can be employed in autoinjector training devices.
  • FIG. 1 illustrates a side cross-sectional view of an autoinjector.
  • FIG. 2 provides a side cross-sectional view of an autoinjector in an activated state in which a needle is extending out of the proximal end of the housing of the autoinjector.
  • FIG. 3 is a side schematic view of an autoinjector having a label comprising a label substrate and a varnish.
  • FIG. 4 is a side schematic view of an autoinjector having a label comprising a label substrate, wherein the label substrate includes indentures and protrusions.
  • FIG. 4A is a section view of the label substrate taken along line 4A-4A in Figure 4.
  • FIG. 5 is a side schematic view of an autoinjector having a label with a matte finish.
  • FIG. 6 is a side schematic view of an autoinjector, wherein the exterior surface of the autoinjector housing forms at least one of indentures and protrusions.
  • FIG. 7 is a side schematic view of an autoinjector having a label, which includes a label substrate and a varnish, wherein the label substrate includes indentures.
  • FIG. 1 is provided to illustrate one embodiment of an autoinjector, designated by the numeral 10.
  • an autoinjector designated by the numeral 10.
  • positional terms such as “upper,” “lower,” “side,” “top,” “bottom,” etc. refer to the apparatus when in the orientation shown in the drawing. The skilled artisan will recognize that the apparatus can assume different orientations when in use.
  • an autoinjector 10 typically includes a housing 12 having an interior surface 14 and an exterior surface 16 and a proximal end 18 and a distal end 20.
  • the housing 12 forms the exterior surface of the autoinjector body and can include one or more structures.
  • the housing 12 comprises a safety pin 13, a cylindrical body 15 and a needle cover 17.
  • An autoinjector 10 also generally includes a needle 22, which has a proximal end 24 and a distal end 26 and is moveable from a needle storage position in which the needle 22 is situated within the housing 12 to a medicament delivering position in which the needle 22 extends out of the proximal end 18 of the housing 12.
  • An autoinjector 10 also typically includes a power assembly 28 for moving the needle 22 from the needle storage position to the medicament delivering position and a liquid medicament 30 that is administered through the needle 22 as the needle 22 moves from the needle storage position to the needle fully extended position.
  • FIG. 2 is provided to illustrate an autoinjector 10 in an activated state in which the needle 22 has moved from the needle storage position.
  • the exterior surface of an autoinjector may be difficult to handle, especially in times of stress. Accordingly, the present invention provides an autoinjector that comprises one or more slip- resistant features.
  • a label comprising a varnish is provided to prepare an autoinjector that includes one or more slip-resistant features.
  • a label 32 including a label substrate 34 and a varnish 36 is attached to the exterior surface 16 of the housing 12 of an autoinjector 10.
  • the varnish 36 coats at least a portion of the label substrate 34.
  • a label substrate is the base upon which printing or other processes are performed to create a label.
  • the label 32 includes a UPC code 38 and one or more words 40 and/or pictures that provide, for example, instructions on how to use the autoinjector 10.
  • the label 32 covers at least about 30% of the exterior surface 16 of the housing 12.
  • the varnish 36 forms a pattern on at least a portion of the label substrate 34. For example, as shown in FIG.
  • the varnish 36 can form a vshaped pattern (also known as a chevron pattern) on the label substrate 34.
  • the varnish 36 can form a wshaped pattern on the label substrate 34.
  • the patterns of the varnish 36 have been enlarged in the drawings in FIGS. 3 and 7 so as to readily illustrate the patterns.
  • the size of the pattern the varnish 36 forms on the label substrate 34 is from about 0.25 millimeters by about 0.25 millimeters to about 2 millimeters by about 2 millimeters. Nonetheless, it will be appreciated that the range provided is exemplary and, for example, the varnish 36 can form larger patterns if desired. It is also preferred that the varnish 36 has one or more rubberized or textured, slip-resistant properties.
  • the varnish 36 can be any suitable material.
  • the varnish 36 can be a solvent- or epoxybased varnish or the varnish can be a varnish that has been cured by ultraviolet light.
  • the varnish 36 has been cured by ultraviolet light.
  • the varnish 36 imparts a slip-resistant texture to at least a portion of the label 32.
  • a gloss varnish is employed so as to facilitate reading of any words and/or pictures on the label while also providing a slip-resistant texture to at least a portion of the label.
  • one or more indentures or protrusions are employed to create a slip-resistant label. More particularly, as illustrated in FIG. 4, a label 32 comprising a label substrate 34 having at least one of indentures 42 and protrusions 44 is attached to the exterior surface 16 of the housing 12 of the autoinjector 10. As shown in FIG. 4A, if present, the indentures 42 extend toward the exterior surface 16 of the housing 12 and the protrusions 44 extend away from the exterior surface 16 of the housing 12. In certain embodiments, the indentures 42 comprise microgrooves. In certain embodiments, the label substrate 34 is thermoformed so as to provide a slip-resistant label 32. In particular embodiments, the label substrate 34 is corrugated.
  • a label 32 which comprises a label substrate 34 and a film 46, is attached to the exterior surface 16 of the housing 12 of the autoinjector 10 to provide a slip-resistant autoinjector.
  • the film 46 coats at least a portion of the label substrate 34 and provides a matte finish to at least a portion of the label 32.
  • the housing of the autoinjector can be molded with a slip-resistant surface or features and then the surface can be over printed with words and/or pictures using various printing processes, including, for example, ink jet printing, pad printing, laser printing, or in mold decorating.
  • the exterior surface 16 of the housing 12 of the autoinjector 10 can form one or more indentations 48 or protrusions 50 to impart a slip-resistant texture.
  • the exterior surface 16 of the housing 12 of the autoinjector 10 can include one or more indentations 48 that are sized and spaced so as to accommodate one or more fingers of a human user or caregiver.
  • the one or more protrusions 50 may form a flange for improving the handling properties of the autoinjector 10. If present, preferably, the flange is located at the proximal end 18 of the housing 12.
  • a label 32 comprising a label substrate 34, which includes indentures 42, and a varnish 36 coating at least a portion of the label substrate 34 can be used to prepare a slip- resistant autoinjector 10.
  • the autoinjector 10 can include both a slip-resistant label 32 as well as a slip-resistant housing 12.
  • the autoinjector 10 can include a slip-resistant label 32 comprising a label substrate 34 and a varnish 36 coating at least a portion of the label substrate 34, and the exterior surface 16 of the housing 12 of the autoinjector 10 can form one or more indentations 48 or protrusions 50 to impart a slip-resistant texture.
  • the label 32 contains words and/or pictures, such as user instructions, and the exterior surface 16 of the housing 12 is over printed with words and/or pictures. It is further preferred in this embodiment that the label 32 covers less than about 30% of the exterior surface 16 of the housing 12.
  • the autoinjector can employ any features or structures known in the art or later developed, including without limitation those described in FIGs. 1 and 2 as well as those described in U.S. Patent Nos. 7,449,012 and 7,811,254, the contents of which are incorporated herein in their entirety.
  • the autoinjector includes a needle and a power assembly as described above.
  • autoinjector training devices resemble autoinjectors but do not include needles or medicaments.
  • Autoinjector training devices are described in, for example, U.S. Patent Nos. 4,640,686 and 5,567,160 and U.S. Patent Publication No. 2007/0111175, the contents of each of which are incorporated by reference in their entirety.
  • the one or more slip-resistant features preferably improve the handling properties of the autoinjector.
  • the slip-resistant features may be especially beneficial if the user's or caregiver's hands are wet, sweaty and/or covered with a lotion such as sunscreen, hand lotion, rubbing alcohol, and/or isopropyl alcohol.
  • any slip- resistant features included on an autoinjector or autoinjector training device do not affect the ease at which the autoinjector or autoinjector training device is manufactured and packaged.
  • the labeling and packaging of autoinjectors often requires that the labels be applied with wipers that can slide over the surface of the labels without resulting in wrinkles, bubbles or creases.
  • any slip-resistant features on the label do not interfere with the ease at which wipers can slide over the surface of the label.
  • the ends of the label may overlap with one another so that a portion of the label is adhered to another portion of the label.
  • the slip-resistant features do not interfere with the ability of a portion of the label to adhere to another portion of the label.
  • autoinjectors are frequently packaged into protective carriers, where they are carried prior to use.
  • the slip-resistant features do not increase the coefficient of friction of the label and/or the exterior surface of the autoinjector to such an extent so as to interfere with the packaging of the autoinjector in the protective carrier or the removal of the autoinjector from the protective carrier prior to use.
  • coating a label substrate may decrease the readability of any printed material included in the label, including, without limitation, a UPC code or instructions.
  • the slip-resistant feature decreases the readability of any printed material to the extent that the material cannot be easily read by a user or computer, preferably, the feature is not included in the portion of the label that needs to be read by a user or computer.
  • words may be imprinted on the label after a slip-resistant coating has been applied to the label substrate.
  • words are not imprinted on the coating.
  • one or more slip-resistant features may be masked so that the features do not contact any features contained in the autoinjector protective carrier, including, without limitation, automation fixture surfaces and ribs in an autoinjector protective carrier.
  • Varnish EOP-18 has a viscosity of about 200 cps
  • Varnish 329 has a viscosity of about 1,500 cps and is thicker than EOP-18
  • Varnish 135 LP has a viscosity of about 120 cps and is tackier than EOP-18 so as to give a "rubbery" or textured feel.
  • Each varnish was then applied to label substrates using seven different plates. One plate was smooth and others had a "v" (chevron) pattern or a bumped pattern.
  • each varnish was applied in a smooth pattern, a standard bumped pattern, a standard "v” pattern, a 50% reduced bump pattern, a 50% reduced "v” pattern, a 150% bump pattern, and a 150% “v” shaped pattern.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un auto-injecteur présentant, dans un mode de réalisation, une ou plusieurs caractéristiques de résistance au glissement. Dans certains modes de réalisation de l'invention, la surface extérieure du boîtier de l'auto-injecteur forme au moins des indentations et/ou saillies qui confèrent au boîtier de l'auto-injecteur une texture résistant au glissement. Dans un autre mode de réalisation de l'invention, ladite ou lesdites caractéristiques de résistance au glissement sont comprises sur une étiquette, qui comporte un substrat d'étiquette et qui est fixée sur la surface extérieure du boîtier de l'auto-injecteur. Les caractéristiques selon l'invention sont destinées à améliorer les propriétés de manipulation de l'auto-injecteur et à réduire la possibilité que l'auto-injecteur glisse de la main d'un utilisateur ou d'une personne administrant les soins pendant son utilisation.
PCT/IB2011/056031 2010-12-30 2011-12-30 Auto-injecteurs résistant au glissement Ceased WO2012090186A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
JP2013546819A JP2014503308A (ja) 2010-12-30 2011-12-30 スリップ防止自動注射器
US13/976,494 US20130281934A1 (en) 2010-12-30 2011-12-30 Slip-Resistant Autoinjectors
EP11813825.4A EP2658588A1 (fr) 2010-12-30 2011-12-30 Auto-injecteurs résistant au glissement
US15/259,145 US20160375196A1 (en) 2010-12-30 2016-09-08 Slip-Resistant Autoinjectors
US16/125,926 US20190022319A1 (en) 2010-12-30 2018-09-10 Slip-Resistant Autoinjectors
US16/913,042 US11844932B2 (en) 2010-12-30 2020-06-26 Slip-resistant autoinjectors

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201061428297P 2010-12-30 2010-12-30
US61/428,297 2010-12-30

Related Child Applications (2)

Application Number Title Priority Date Filing Date
US13/976,494 A-371-Of-International US20130281934A1 (en) 2010-12-30 2011-12-30 Slip-Resistant Autoinjectors
US15/259,145 Continuation US20160375196A1 (en) 2010-12-30 2016-09-08 Slip-Resistant Autoinjectors

Publications (1)

Publication Number Publication Date
WO2012090186A1 true WO2012090186A1 (fr) 2012-07-05

Family

ID=45554764

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2011/056031 Ceased WO2012090186A1 (fr) 2010-12-30 2011-12-30 Auto-injecteurs résistant au glissement

Country Status (4)

Country Link
US (4) US20130281934A1 (fr)
EP (1) EP2658588A1 (fr)
JP (1) JP2014503308A (fr)
WO (1) WO2012090186A1 (fr)

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US9707354B2 (en) 2013-03-11 2017-07-18 Antares Pharma, Inc. Multiple dosage injector with rack and pinion dosage system
US9744302B2 (en) 2013-02-11 2017-08-29 Antares Pharma, Inc. Needle assisted jet injection device having reduced trigger force
US9808582B2 (en) 2006-05-03 2017-11-07 Antares Pharma, Inc. Two-stage reconstituting injector
US9867949B2 (en) 2008-03-10 2018-01-16 Antares Pharma, Inc. Injector safety device
US9950125B2 (en) 2012-04-06 2018-04-24 Antares Pharma, Inc. Needle assisted jet injection administration of testosterone compositions
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JP1629609S (fr) 2017-10-25 2019-04-15
USD903856S1 (en) 2018-06-29 2020-12-01 Regeneron Pharmaceuticals, Inc. Auto-injector
USD932006S1 (en) 2018-11-21 2021-09-28 Regeneron Pharmaceuticals, Inc. Auto-injector cap
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US11844932B2 (en) 2023-12-19
EP2658588A1 (fr) 2013-11-06
JP2014503308A (ja) 2014-02-13
US20160375196A1 (en) 2016-12-29
US20130281934A1 (en) 2013-10-24
US20200324049A1 (en) 2020-10-15
US20190022319A1 (en) 2019-01-24

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